Phase 2
N=12
Effects of b3-Adrenergic Receptor Agonists on Brown Adipose Tissue
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01783470 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: BAT Activity as Measured by 18F-FDG PET/CT — 0.92; 132 mL*SUVmean*g/mL — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- beta3-adrenergic receptor agonist (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Aaron Cypess
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BAT Activity as Measured by 18F-FDG PET/CT |
0.92; 132 | 0.001 sig |
Summary
This study will test the hypothesis that human brown adipose tissue (BAT) can be activated using a β3-adrenergic receptor (AR) agonist. The efficacy of β3-AR agonist will be compared with cold exposure, which we have already shown can activate human BAT, as well as a placebo control.
Eligibility Criteria
Inclusion Criteria
- Healthy Male
- 18-65 years old
- BMI between 18-40
- Not participated in clinical trial and received either an investigational or marketed drug within two months prior to the study
- Not donated blood in previous two months
Exclusion Criteria
- Women
- History of local or systemic infection disease with fever or requiring antibiotic within 4 weeks of drug administration
- Corrected QT interval above normal
- Laboratory test results that is more than 1.5 fold outside normal range and/or is judged to be clinically significant
- Current addition to alcohol or substances of abuse
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Use of system course of corticosteroids or other medication known to cause insulin resistance in previous 6 weeks
- Hyperthyroidism, hypothyroidism, hypertension (even if controlled with medications), heart disease (including CAD and CHF), cardiac arrhythmias, diabetes, unstable vasomotor system, or use of monoamine oxidase (MAO) inhibitors
- Diagnosis of bladder outlet obstruction or use of any medication to treat overactive bladder (e.g. Tolterodine, Solifenacin, Propiverine, Oxybutynin, and Fesoterodine)
Data sourced from ClinicalTrials.gov (NCT01783470). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.